FDA.reportPublic FDA data

NiniFilter NRFit

Primary DI
14048223031312
Brand
NiniFilter NRFit
Company
Pajunk GmbH Medizintechnologie
Model
001163-38K
Catalog number
001163-38K
Published
2020-07-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSNFILTER, CONDUCTION, ANESTHETIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSNFilter, Conduction, AnestheticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190663000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190663000Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6PAJUNK GmbH Medizintechnologie2019-06-17BSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14048223031312PrimaryGS10
04048223031315Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404822303131214048223031312
04048223031315040482230313154048223031315

GMDN Terms#

Term, Definition table
TermDefinition
Local/regional anaesthesia conduction filterA microporous membrane used to minimize particulate (foreign material) contamination of a local anaesthetic during subcutaneous administration to a patient (e.g., through a spinal or epidural catheter); it may in addition be intended for use during medication administration or preparation. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(888)972-5865info@pajunk-usa.com

Regulatory Flags#

DUNS number
317654283
Device count
10
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048223049860MANOMETER001163-38F001163-38F2021-04-02
04048223050163RFTL001165-20C001165-20C2021-04-02
04048223050248RFTL001165-30D001165-30D2021-04-02
04048223051757SONOPLEX001285-71001285-712021-04-02
04048223051801SONOPLEX001285-77001285-772021-04-02
04048223052303RFTL011165-40D011165-40D2021-04-02
04048223102541UNIPLEX® NANOLINE001156-72001156-722021-04-02
04048223102572UNIPLEX® NANOLINE001156-77001156-772021-04-02
04048223103319SONOBLOCK001180-71001180-712021-04-02
04048223103449SONOPLEX001185-71001185-712021-04-02
04048223103463SONOPLEX001185-74001185-742021-04-02
04048223103562SONOPLEX001187-74001187-742021-04-02
04048223107058SONOTAP1185-3E0501185-3E0502021-04-02
04048223115756TUOHY1150-7G1031150-7G1032021-07-07
04048223116043SONO MSK1191-4C0501191-4C0502021-07-07
04048223116074SONO MSK1191-4E0701191-4E0702021-07-07
04048223116081SONO MSK1191-4E0901191-4E0902021-07-07
04048223116098SONO MSK1191-4E1001191-4E1002021-07-07
04048223116265SONOTAP II1285-3E0501285-3E0502021-07-07
04048223116272SONOTAP II1285-3E0801285-3E0802021-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223120316FilterPajunk GmbH MedizintechnologieBSN2025-04-04
04048223120323FilterPajunk GmbH MedizintechnologieBSN2025-04-04
04048223069585MiniFilter 0,2µmPajunk GmbH MedizintechnologieBSN2025-01-30
04048223048993MiniFilter 0,2µmPajunk GmbH MedizintechnologieBSN2025-01-30
00840178703477ITDTouchpoint Medical, Inc.BSN2024-09-16
05060498301411Dash 6GBUK GROUP LIMITEDBSN2024-01-22
05060498301442Dash 6GBUK GROUP LIMITEDBSN2024-01-22
05060498301565Dash 6GBUK GROUP LIMITEDBSN2024-01-22
05060498301688Dash 6GBUK GROUP LIMITEDBSN2024-01-22
05060498306881Dash 6GBUK GROUP LIMITEDBSN2024-01-22
05060498306904Dash 6GBUK GROUP LIMITEDBSN2024-01-22
05060498306980Dash 6GBUK GROUP LIMITEDBSN2024-01-22
05060498301435Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301459Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301572Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301695Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498302289Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498302265Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498302104Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498306911Dash 6GBUK GROUP LIMITEDBSN2023-06-02
05060498302227Dash 6INTERVENE GROUP LIMITEDBSN2023-06-02
04048223049877FILTERPajunk GmbH MedizintechnologieBSN2021-04-02
04048223050064FILTERPajunk GmbH MedizintechnologieBSN2021-04-02
14048223041793Filter NRFitPajunk GmbH MedizintechnologieBSN2020-07-22
04048223031315NiniFilter NRFitPajunk GmbH MedizintechnologieBSN2020-07-22
04048223041796Filter NRFitPajunk GmbH MedizintechnologieBSN2020-07-22
15019315107283PortexICU MEDICAL, INC.BSN2020-06-22
35019315107287PortexSmiths Medical Czech Republic a.s.BSN2020-06-22
15019517054651PortexICU MEDICAL, INC.BSN2020-03-09
15019517071368PortexICU MEDICAL, INC.BSN2020-03-09